Chest
Volume 136, Issue 2, August 2009, Pages 340-346
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Original Research
Interventional Pulmonology
A Randomized Controlled Trial of Standard vs Endobronchial Ultrasonography-Guided Transbronchial Needle Aspiration in Patients With Suspected Sarcoidosis

https://doi.org/10.1378/chest.08-2768Get rights and content

Background

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) of mediastinal lymph nodes has been found to be more accurate than standard TBNA in the setting of malignancy. In patients with suspected sarcoidosis, the smaller ultrasound needle may yield inadequate material to make a histologic diagnosis of granulomatous inflammation. The aim of this study was to compare the diagnostic yield of EBUS-guided TBNA to TBNA performed with a standard 19-gauge needle in patients with mediastinal adenopathy and a clinical suspicion of sarcoidosis.

Methods

A randomized controlled trial was performed in a university medical center, enrolling 50 patients (of 61 screened, 2 declined, and 9 did not meet entry criteria) with hilar and/or mediastinal adenopathy and a clinical suspicion of sarcoidosis. Twenty-four patients were randomized to undergo EBUS-guided TBNA and 26 to undergo TBNA using a standard 19-gauge needle.

Results

The primary outcome measure of diagnostic yield was 53.8% vs 83.3% in favor of the EBUS-guided TBNA group, an absolute increase of 29.5% (p < 0.05; 95% confidence interval [CI], 8.6 to 55.4%). After blinded research pathology review, diagnostic yield was 73.1% vs 95.8%, in favor of the EBUS-guided TBNA group, an absolute increase of 22.7% (p = 0.05; 95% CI, 1.9 to 42.2%). Sensitivity and specificity were 60.9% and 100%, respectively, in the standard TBNA group, and 83.3% and 100%, respectively, in the EBUS-guided TBNA group (absolute increase in sensitivity, 22.5%; p = 0.085; 95% CI, 3.2 to 44.9%).

Conclusions

The diagnostic yield of EBUS-guided TBNA is superior to TBNA using a standard 19-gauge needle for sampling of mediastinal lymph nodes in patients with a clinical suspicion of sarcoidosis.

Trial registration

ClinicalTrials.gov Identifier: NCT00373555

Section snippets

Study Design

This single-center study employed a randomized controlled design, with blinded analysis of the cytopathologic samples. The protocol was approved by the Conjoint Health Research Ethics Board of the University of Calgary, and written informed consent was obtained from all patients.

Patients were eligible for this study if they were ≥ 16 years of age, had pathologic mediastinal or hilar adenopathy (short axis, > 1 cm) confirmed on CT scan of the chest, were considered to have a likely diagnosis of

Results

Sixty-one patients were screened and 50 were randomized (Fig 1) between September 2006 and August 2007. Chart review was completed between June 2008 and August 2008. Baseline characteristics can be found in Table 1. All patients underwent mediastinal lymph node aspiration according to their assigned randomization group. Bronchoscopy was performed by interventional pulmonary medicine fellows assisted by a dedicated interventional pulmonary medicine physician in 48 of the 50 cases, with 2 cases

Discussion

EBUS is rapidly changing the assessment of the mediastinum, especially in patients with suspected lung malignancies in whom diagnostic yields and sensitivities of > 90% have been achieved.12, 13, 15, 20, 21 Interestingly, there has yet to be a randomized controlled study comparing linear EBUS-guided TBNA with standard TBNA in any patient population, although one randomized study27 did show the superiority of balloon probe radial, EBUS-guided TBNA vs standard TBNA.

In patients with suspected

Acknowledgments

Author contributions: All authors were involved with the acquisition, analysis, and interpretation of data. Drs. Tremblay, Stather, and Field were involved with the conception and design. Dr. Tremblay was involved with the drafting of the manuscript, statistical analysis, obtaining funding, and supervision of the study. Drs. Stather, MacEachern, Khalil, and Field were involved with the critical revision of the manuscript.

Financial/nonfinancial disclosures: The authors have reported to the ACCP

References (0)

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Funding/Support: The University of Calgary has received unrestricted educational grant support from Olympus Canada for support of continuing medical education courses on endobronchial ultrasonography, as well as for support of the interventional pulmonary medicine training program. Funding was received from the Jack Mackenzie Memorial Fund.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/site/misc/reprints.xhtml).

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